MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Rash (2033); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3 - date of event - unknown date in october 2018.D10 - concomitant devices - nexgen rotating hinge knee precoat cemented tibial component size 5 catalog #: 00588000500, lot #: 63922979, nexgen rotating hinge knee articular surface size e 12mm with hinge post catalog #: 0588005012, lot #: 63114501, nexgen tibial augment block size 5 10mm catalog #: 00588000510, lot #: 62925333, nexgen sharp fluted stem extension 75mm x 120mm catalog #: 00598801510, lot #: 62569143, nexgen posterior femoral augment block size e 5mm catalog #: 00599003501, lot #: 63765760, nexgen distal femoral augment block size e 10mm catalog #: 00599003520, lot #: 63814122, nexgen distal femoral augment block catalog #: 00599003520, lot #: 63725364, nexgen long sharp fluted stem 130mm x 175mm catalog#: 00598801610, lot #: 63333202.H6 - component code - proposed code is mechanical (g04) - femur.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient experienced a fracture of the femoral hinge pin bushing approximately five (5) months following left knee arthroplasty while walking.Since this occurred, the patient has experienced instability, pain and a rash.The patient is unable to undergo a revision procedure to correct the outcome due to risk of further damage to the patient's bones.Initial operative notes noted no intraoperative complications.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Radiographic review identified a small, metallic fragment or structure of unknown etiology and significance projecting over the lateral femoral condyle component.Medical records provided confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT LEFT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22183621
• Report Number: 0001822565-2025-01835
• Device Sequence Number: 12915886
• Product Code: JWH
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)221130(10)63801681
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 63801681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 95 KG